Kisspeptin Administration Subcutaneously to Patients With Reproductive Disorders

Description

The goal of this study is to see whether kisspeptin, a naturally occurring hormone, can stimulate the release of other reproductive hormones in women with hypothalamic amenorrhea (HA). The investigators are also examining whether kisspeptin can help women release eggs from their ovaries. Kisspeptin will be administered subcutaneously (SC) for two weeks in a pulsatile fashion. Ultrasound monitoring of ovarian follicular growth and frequent blood sampling (every 10 minutes for up to two hours) will be performed to assess the physiologic response to kisspeptin over time.

Conditions

Hypothalamic Amenorrhea, Hypogonadotropic Hypogonadism

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Study Overview

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Study Details

Study overview

The goal of this study is to see whether kisspeptin, a naturally occurring hormone, can stimulate the release of other reproductive hormones in women with hypothalamic amenorrhea (HA). The investigators are also examining whether kisspeptin can help women release eggs from their ovaries. Kisspeptin will be administered subcutaneously (SC) for two weeks in a pulsatile fashion. Ultrasound monitoring of ovarian follicular growth and frequent blood sampling (every 10 minutes for up to two hours) will be performed to assess the physiologic response to kisspeptin over time.

Kisspeptin Administration Subcutaneously to Patients With Reproductive Disorders

Kisspeptin Administration Subcutaneously to Patients With Reproductive Disorders

Condition
Hypothalamic Amenorrhea
Intervention / Treatment

-

Contacts and Locations

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Acquired hypogonadotropic hypogonadism (hypothalamic amenorrhea, aka functional hypothalamic amenorrhea)
  • * Normal blood pressure (systolic BP \< 140 mm Hg, diastolic \< 90 mm Hg)
  • * Laboratory Studies:
  • * Hemoglobin no less than 0.5 g/dL below the lower limit of the reference range for normal women
  • * Negative serum hCG pregnancy test at screening (additional urine pregnancy test will be conducted prior to drug administration)
  • * Not using hormonal replacement or willing to complete an appropriate washout for that particular medication and method of administration
  • * No current or recent use of a medication that, in the opinion of a study investigator, can modulate the reproductive axis or willing to complete an appropriate washout for that particular medication and method of administration
  • * Any condition (medical, mental, or behavioral) that, in the opinion of a study investigator, would likely interfere with participation in/completion of the protocol
  • * Excessive alcohol consumption (\>10 drinks/week) and/or active use of illicit drugs
  • * Pregnant or trying to become pregnant
  • * Breast feeding
  • * History of bilateral oophorectomy (ovaries were removed)

Ages Eligible for Study

18 Years to 45 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Stephanie B. Seminara, MD,

Stephanie Seminara, MD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

2025-12